Acid Suppressing Drug Seizure Epidemiology Study

AstraZeneca8,605 enrolled

Overview

The purpose of this study is 1. to estimate the incidence of seizure in the general population and stratified by epilepsy status 2. To estimate the relative risk of seizure associated with use of proton pump inhibitors and histamine 2 receptor antagonist and stratified by epilepsy status

A cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK

Study Type

OBSERVATIONAL

Enrollment

8,605

Conditions

Seizure

Interventions

Risk of seizureDRUG

Patients newly prescribed PPI and H2RA, respectively

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Primary care physician for at least 2 years. * Computerized prescription history of at least 1 year. * Patients will have to be free of acid-suppressing drugs (PPI or H2RA) for at least one year. * No diagnosis of cancer. * No alcohol abuse or alcohol-related disease- No drug abuse. Exclusion Criteria: * Patients with at least 1 prescription of PPI or H2RA in the year prior to start date. * Cancer before start date. * Alcohol abuse or alcohol-related disease before start date. * Drug abuse before start date.

Locations (1)

Research Site

Madrid, Spain

Outcomes

Primary Outcomes

Incidence of seizure in the general population and stratified by epilepsy status.

Time frame: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.

Follow-up of safety outcomes: First recorded entry of seizure.

Time frame: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.

Data from ClinicalTrials.gov

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